BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP, TSV, 4.7,10,MTX,MC,MG,HA

    MDR report key: 14175181 · Received April 21, 2022

    Report

    Report Number
    0002023141-2022-00960
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Date of Event
    March 1, 2022
    Report Date
    October 11, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344143
    PMA / PMN Number
    K101880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. CATALOG, LOT NUMBER, EXPIRATION DATE AND UNIQUE IDENTIFIER (UDI) NUMBER UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER ¿ K133339. DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER CMP-(B)(4). THE REPORTED DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED PRODUCT IDENTIFIED THE IMPLANT WITH SIGNS OF USE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT; VERIFIED THE IMPLANT WAS UNABLE TO DISENGAGE/RELEASE FROM THE MOUNT. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PRODUCT EXPERIENCE REPORT (PER). THE PATIENT WAS REPORTED TO HAVE HIGH DENSITY (TYPE I) BONE. THE REPORTED DEVICE WAS LOCATED ON TOOTH # 19 AND WAS PLACED AND REMOVED ON THE SAME DAY. A DEVICE HISTORY RECORD (DHR)REVIEW WAS PERFORMED AND NO RELATED DEVIATIONS OR NONCONFORMANCES WERE NOTED. ALSO, A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WAS ONE RELATED COMPLAINTS FOR THIS PRODUCT LOT. COMPLAINANT REPORTED THAT THE IMPLANT BODY COULD NOT BE REMOVED FROM THE FIXTURE MOUNT. THE REPORTED COMPLAINT WAS CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867081 IMP, TSV, 4.7,10,MTX,MC,MG,HA DENTAL IMPLANT DZE ZIMMER DENTAL TSVMWH10 1241578 00889024344143

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male